Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01496157
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2011-12-13
Brief Title:
Evaluation of Prostate-specific Membrane Antigen PSMA-Based PET Imaging of Primary Prostate Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen PSMA 18FDCFBC DCFBC as a PET imaging biomarker of prostate cancer detection and aggressiveness at initial diagnosis PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for PSMA detection and monitoring is not currently available Development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer imaging The investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis DCFBC uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities CT bone scan and biopsy results when available In addition DCFBC-PET uptake quantification will be compared with expression levels of PSMA and other prostate cancer relevant markers PSA Ki-67 TMPRSS2-ERG by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers PSA Gleason score clinical stage Partin tables derived prediction of pathologic stage
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NA_00051395 | OTHER | JHMIRB | None |